Methods for treating nephrotic syndrome

Abstract

Described herein are methods for treating nephrotic syndrome using an anti-CD20 antibody. In one embodiment, that anti-CD20 antibody is Obinutuzumab.

The invention claimed is: 
     
       1. A method of treating, inhibiting or reducing severity of nephrotic syndrome or glomerulonephritis in a subject in need thereof, wherein the subject is a transplant recipient, the method consisting of:
 administering an effective amount of an anti-CD20 antibody, or a pharmaceutical composition consisting of the anti-CD20 antibody and a pharmaceutically acceptable excipient, in two or more doses over a period of no more than 21 days to the subject after transplantation, or 
 administering an effective amount of the anti-CD20 antibody or the pharmaceutical composition in the two or more doses over a period of no more than 21 days and a standard-of-care treatment to the subject, 
 wherein the anti-CD20 antibody comprises Obinutuzumab, so as to treat, inhibit or reduce the severity of nephrotic syndrome or glomerulonephritis in the subject. 
 
     
     
       2. The method of  claim 1 , for treating, inhibiting or reducing the severity of glomerulonephritis in the subject in need thereof, and the glomerulonephritis is membranous glomerulonephritis. 
     
     
       3. The method of  claim 1 , wherein the glomerulonephritis is membranous glomerulonephritis, focal segmental glomerulosclerosis (FSGS), minimal change nephrotic syndrome, cryoglobulinemic glomerulonephritis, or IgA nephropathy. 
     
     
       4. The method of  claim 1 , wherein the anti-CD20 antibody comprises Obinutuzumab and Rituximab. 
     
     
       5. The method of  claim 1 , wherein the subject has Rituximab-resistant nephrotic syndrome or the subject has relapsed from a previous rituximab treatment. 
     
     
       6. The method of  claim 1 , wherein the nephrotic syndrome in the subject is caused by any one or more of minimal change disease, focal segmental glomerulosclerosis, membranous glomerulonephritis, IgA nephropathy and cryoglobulinemic glomerulonephritis. 
     
     
       7. The method of  claim 1 , wherein the subject has been administered a standard-of-care treatment prior to the administration of the anti-CD20 antibody. 
     
     
       8. The method of  claim 7 , wherein the subject does not respond to the standard-of-care treatment prior to the administration of the anti-CD20 antibody. 
     
     
       9. The method of  claim 1 , consisting of the administration of the anti-CD20 antibody or the pharmaceutical composition and the standard-of-care treatment, wherein the anti-CD20 antibody is administered simultaneously or sequentially with the standard-of-care treatment. 
     
     
       10. The method of  claim 7 , wherein the standard-of-care treatment is any one or more of a steroid, mycophenolic acid, mycophenolate mofetil, and a calcineurin inhibitor, wherein the calcineurin inhibitor comprises cyclosporine, tacrolimus, or a combination thereof. 
     
     
       11. The method of  claim 1 , wherein the effective amount of the anti-CD20 antibody is about 0.1 to 1000 mg of the anti-CD20 antibody/kg of the subject/day. 
     
     
       12. The method of  claim 1 , wherein the anti-CD20 antibody is administered to the subject 1-3 times per day or 1-7 times per week. 
     
     
       13. The method of  claim 1 , wherein the anti-CD20 antibody is Obinutuzumab, which is administered to the subject for 1-5 days. 
     
     
       14. The method of  claim 1 , wherein the effective amount is two doses of 1 g Obinutuzumab per dose, wherein a first dose is administered on the same day or over two days. 
     
     
       15. The method of  claim 14 , wherein the Obinutuzumab is administered intravenously. 
     
     
       16. The method of  claim 14 , wherein the two doses are administered 15 days apart. 
     
     
       17. The method of  claim 14 , wherein the first dose is administered in an amount of 100 mg on day 1 and 900 mg on day 2. 
     
     
       18. The method of  claim 1 , wherein the subject is human. 
     
     
       19. A method of treating, inhibiting or reducing severity of lupus nephritis in a subject in need thereof, wherein the subject is a transplant recipient, the method consisting of: administering an effective amount of an anti-CD20 antibody, or a pharmaceutical composition consisting of the anti-CD20 antibody and a pharmaceutically acceptable excipient, in two or more doses over a period of no more than 21 days to the subject during or after the subject receives a kidney transplant, or administering an effective amount of the anti-CD20 antibody or the pharmaceutical composition in the two or more doses over a period of no more than 21 days and a standard-of-care treatment to the subject during or after the subject receives a kidney transplant, wherein the anti-CD20 antibody comprises Obinutuzumab, so as to treat, inhibit or reduce the severity of lupus nephritis in the subject. 
     
     
       20. The method of  claim 1 , wherein the subject is a kidney transplant recipient.